Peters, K.M., et al. (2010). Presentation, Society for Urodynamics and Female Urology, St. Petersburg, FL.
INTRODUCTION: Overactive bladder (OAB) affects millions of people and is often refractory to standard therapies. Percutaneous Tibial Nerve Stimulation (PTNS) is effective, but a validated sham-controlled trial with PTNS has not previously been reported.
OBJECTIVE: The objective of this study was to compare the efficacy of PTNS to a validated sham in subjects with OAB syndrome.
METHODS: This multi-center, double-blinded, IRB-approved trial enrolled 220 subjects; 110 randomized to PTNS, and 110 randomized to a validated sham intervention. Subjects and study coordinators were blinded to the intervention. Voiding diaries and validated questionnaires were completed at baseline and after 6 and 12 interventions. PTNS stimulation was delivered through a 34-gauge needle electrode inserted near the posterior tibial nerve using the Urgent PC®device for 12 weekly 30-minute sessions. A surface electrode and 2 sham electrode pads were placed for consistency with the sham. The sham used a Streitberger placebo needle that provided the sensation of a needle, but did not pierce the skin as it retracted into its shaft. Also, TENS electrode pads were placed above and below the small toe providing the sensation of stimulation without tibial nerve activation. An inactive surface electrode was placed as in PTNS. The audible PTNS device sounds were also reproduced in the sham intervention to diminish auditory variation between groups. The primary endpoint was an intent-to-treat analysis of the subjects’ 7-point Global Response Assessment (GRA).
RESULTS: The GRA found 54.5% were responders (moderately or markedly improved) in the PTNS group compared to 20.9% in the sham group (p<0.001). The PTNS group had statistically significant improvement for urinary urgency, frequency, and urge incontinence on the GRA compared to sham group (p<0.02). The OAB-q symptom severity score and quality of life scores showed statistically significant improvement in the PTNS group compared to the sham group (p<0.01). 52.4% of PTNS and 58.1% of sham subjects correctly guessed their intervention confirming an adequate sham. No serious adverse effects were noted.
CONCLUSIONS: This study provides Level I evidence that the therapeutic effect of PTNS is not due to a placebo effect but rather to stimulation of the tibial nerve with significant improvement in OAB symptoms. PTNS is effective, lacks major side effects and may be considered a primary treatment for OAB symptoms.
Source: Original Presentation
